Uliprist 5 mg (Tablet)

Indications

• Used before surgery to treat moderate to severe symptoms of uterine fibroids
• Noncancerous (benign) tumors of the womb (uterus)
• Used in adult women who have not yet reached menopause

Pharmacology

• Selective progesterone receptor modulator
• Blocks the receptor of a hormone called progesterone
• Controls the growth of the lining of the womb

Dosage & Administration

• Taken by mouth
• Recommended dose is one tablet (5 mg) a day for up to three months
• Treatment should always be started during the first week of the menstrual cycle

Contraindications

• Hypersensitivity to the active substance or to any of the excipients
• Pregnancy and breastfeeding
• Genital bleeding of unknown etiology or for reasons other than uterine fibroids
• Uterine, cervical, ovarian or breast cancer

Side Effects

• Endometrial thickening
• Hot flush
• Headache
• Uterine hemorrhage

Pregnancy & Lactation

• Pregnancy Category X
• Contraindicated during pregnancy
• Excreted in human milk and is not recommended

Precautions & Warnings

• Prescribed after careful diagnosis
• Pregnancy should be precluded prior to treatment
• Concomitant use of progestagen-only pills is not recommended
• Endometrial Thickening or Progesterone receptor modulator Associated Endometrial Changes (PAEC)
• Significant reduction in menstrual blood loss or amenorrhea within the first 10 days of treatment
• Use in women with severe asthma insufficiently controlled by oral glucocorticoids is not recommended

Use in Special Populations

• Not recommended in patients with severe hepatic impairment unless closely monitored
• Renal impairment is not expected to significantly alter the elimination
• Not recommended for patients with moderate and severe renal impairment unless closely monitored

Overdose Effects

• Experience with Uliprist overdose is limited
• No severe or serious adverse reactions reported

Therapeutic Class

• Drugs acting on the Uterus

Storage Conditions

• Keep protected from light & moisture
• Store below 25°C
• Keep out of reach of children

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